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Monograph Development Process for the European Pharmacopoeia: How to participate in the work programme of the European Pharmacopoeia. Dr Claude Coune Head of the Publication and IT division. 4 procedures. Procedure 1: group of experts Procedure 2: adaptation of existing national monograph

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Monograph Development Process for the European Pharmacopoeia: How to participate in the work programme of the European Pharmacopoeia

Dr Claude Coune

Head of the Publication and IT division

4 procedures
4 procedures
  • Procedure 1: group of experts
  • Procedure 2: adaptation of existing national monograph
  • Procedure 3: direct co-operation with innovator, work co-ordinated by national pharmacopoeia
  • Procedure 4: direct co-operation with innovator, work co-ordinated by EDQM
stages in elaboration
Stages in elaboration
  • All four procedures :
    • Addition to work programme by Commission: public announcement (industry associations, Pharmeuropa, web site)
    • Interested parties can (and should!) express an interest
    • Elaboration, experimental checking of draft
    • Publication in Pharmeuropa (3-month comment period)
stages in elaboration 2
Stages in elaboration (2)
    • Study of comments by group of experts/working party
    • Submission to Commission for adoption
    • Publication within 6 months
    • Implementation 1 year after adoption
  • Overall timescale: minimum 2-3 years
work status
Work status
  • Key to information on status:

0 = on the work programme, no first draft

1 = first draft (new or revised monograph)

2 = published (or in press) in Pharmeuropa

3 = submitted to the Commission

4 = adopted, ready for publication

5 = published

work programme
Work programme
  • Based on proposals from:
    • National delegations
    • Groups of experts
    • EDQM
  • Manufacturers can submit proposals via one of the above
work programme 2
Work programme (2)
  • Additions announced on web site
  • Search engine at www.pheur.org for complete work programme
  • Communication via industry associations
new monographs actives
New monographs: actives
  • For active substances, aim is to have monograph ≥ 2 years before patent expiry
  • Addition to programme depends on:
    • therapeutic importance
    • extent of use
    • number of countries in which product is approved
    • known quality problems
new monographs excipients
New monographs: excipients
  • For excipients, important criteria are:
    • extent of use
    • type of use (parenteral, oral, etc)
    • number of preparations in which the excipient is used
    • known quality problems
how to participate
How to participate
  • Participation depends on the procedure used
  • For all procedures it is in your interest to provide samples for testing
  • Information on actives and excipients in approved products is needed
procedure 1
Procedure 1
  • Declare an interest in the monograph being elaborated or revised
  • Indicate willingness to provide samples and to work with the group
  • EDQM will organise contact with co-ordinator for the monograph
direct participation
Direct participation
  • Join a group of experts: contact your national pharmacopoeia authority, which makes proposals for experts
  • Work as a co-opted expert for a particular project that is of interest: short-term commitment
procedures 3 4
Procedures 3 & 4
  • EDQM contacts the innovator to determine willingness to work on monograph
  • Close co-operation during elaboration
  • Will be used systematically for single-source products in future
proposing a new monograph
Proposing a new monograph
  • Contact your National Pharmacopoeia Authority (in Europe) or EDQM (outside Europe)
  • Initial data: countries where the product is approved
  • Data package:
    • Current specification
    • Validation reports
    • Samples of substances and impurities
    • Full description of data package is available
pharmacopoeia liaison
Pharmacopoeia liaison
  • EDQM wishes to have a pharmacopoeia liaison contact for each major manufacturer/user
  • Channel information and requests from manufacturer to EDQM
  • Reception point for contact by EDQM
  • Benefits for both sides
revision
Revision
  • Types of revision:
    • Correction of a monograph/general chapter
    • Minor revision
    • Routine revision
    • Rapid revision
corrections
Corrections
  • Correction of obvious errors (typos, etc.)
  • Dealt with by Secretariat, notification to Commission and national authorities
  • No Pharmeuropa publication
  • Effective from the official publication date of the edition/supplement
  • Occasionally used for rapid implementation of a true revision
minor revision
Minor revision
  • Minor technical changes that do not need to be published for consultation in Pharmeuropa
  • Adopted by Commission on the basis of a briefing note
  • Implemented with other revisions in next edition/supplement
routine revision
Routine revision
  • Based on request for revision with sufficient data
  • Studied by group of experts
  • Published in Pharmeuropa
  • Adopted by Commission
  • Implemented in next edition/supplement
rapid revision
Rapid revision
  • Special procedure intended for use where there is a serious public health concern
  • Cumbersome (publication of resolution and in official journal of each Member State) and not very rapid
  • Rarely used nowadays, “correction” preferred (faster and simpler)
revision programme
Revision programme
  • Work programme is announced via web site
  • Declare an interest for relevant items
  • Make sure you see Pharmeuropa for revision proposals
  • Provide samples, test draft proposal
revision why
Revision: why?
  • New sources have new impurity profiles
  • Quality improves, monograph should keep in line
  • New quality issues arise
  • Analytical methods change: more convenient methods, more powerful methods, more reliable methods become available
  • International harmonisation (PDG, ICH, VICH)
revision why 2
Revision: why? (2)
  • FAQ: “Why did you revise the monograph on…?”
  • You can find out via:
    • Briefing notes in Pharmeuropa
    • Collected briefing notes posted on the web site for each new edition/supplement
  • There is no briefing note for corrections
how to request revision
How to request revision
  • Commission decides on revision
  • Based on proposals from:
    • National delegations
    • Groups of experts
    • EDQM
  • Manufacturers should submit via one of these
how to request revision 2
How to request revision (2)
  • Europe: via national pharmacopoeia authority (address list in Pharmeuropa)
  • Outside Europe: contact EDQM which will refer the matter to a group of experts or to the Commission
  • Make clear what needs revising and if possible make a concrete proposal
data for revision
Data for revision
  • Revision can only be undertaken if the request is backed up by sufficient data
  • Give batch data, sample chromatograms, etc. to enable a decision on the need for revision
special revision programme
Special revision programme
  • Instituted in 2004 to replace TLC by quantitative methods in about 140 monographs on APIs
  • Phase 1: 2004-6, 40 monographs on APIs + 20 amino acids
  • Manufacturers invited to submit data
  • Information available on web site
traditional medicines
Traditional Medicines
  • 50 Chinese Traditional Medicines (herbals),
    • About 15 published, or about to be published
  • Other traditions: Indian (?), South America
knowledge database
Knowledge database
  • The whole programme of the European Pharmacopoeia
    • All published monographs
    • All monographs under elaboration
    • All monographs accepted for elaboration
    • Links to the catalogue of reference standards
    • Links to the Certification database
    • Additional information